There are certain medical procedures, such as interventional or endovascular procedures wherein imaging of the blood vessels and imaging of devices within the blood vessels, that are typically conducted using C-arm imaging apparatus.
Once the patient is properly situated on a table top, the C-arm of such systems is caused to pass or sweep around the patient.
Certain systems are affixed to the ceiling and/or floor. Such systems require an extensive support structure. One of the disadvantages to these systems is that since they are fixed to the building, they require a dedicated room. Fixed attachment within a dedicated room limits the types of procedures that can be done with such equipment and creates scheduling problems.
Other disadvantages are that since the equipment is fixed to the building and require support structures, the dedicated room must be extensively prepared. There are expensive construction costs. Time required to construct, modify and/or prepare the dedicated room and install the associated systems is costly, creates problems within what is supposed to be a sterile environment. This is particularly true if such systems are installed in or near operating rooms. Furthermore, such rooms cannot be used during the construction, modification, preparation, and installation phases associated with such equipment and systems.
Ceiling suspended systems can create additional problems within what must be a sterile environment within operating rooms. For example, debris must not fall from overhead structures and equipment or from their related and required support structures, that are often positioned directly above the patient and operating table. Furthermore, suspended systems can cause interference with other overhead equipment and devices, such as lighting, sterile room ventilation equipment, and anesthesia devices, that are often found within operating rooms.
Due to excessive costs, immobility, and the inflexibility of using such equipment within dedicated rooms, mobile or portable C-arm x-ray imaging systems were created. One example is the Philips BV212 x-ray system. Such systems were sufficiently smaller and mobile to enable the device to be pushed or pulled manually into a surgery or operating room. In other words, such devices were manually pushed or pulled around from room to room within a hospital or clinic.
Once such C-arm is placed into position along the patient table, the imaging procedures of the blood vessels or tracking/chasing of devices within the blood vessels were performed. During these procedures, the C-arm device was manually pushed or pulled along the length of the patient table. In most cases, multiple positioning is required in order to perform the entire procedure. For example, typically, a single image is taken with the C-arm over the chest portion of the patient. When the time arrives, a second image is taken with the C-arm repositioned over the thighs of the patient. Thereafter, the C-arm is again repositioned down to the patient's lower extremities where another imaging process is performed. Because of the size, weight, and multitude of simultaneous functions needed to performed with the mobile C-arm device, it is very difficult and burdensome to accomplish accurate movement of such systems.
In addition, because such mobile C-arm systems are manually maneuvered, it is arduous, if not impossible, to simultaneously move the device longitudinally and vertically at the same time, such as within an X-Y coordinate system.
Furthermore, the tracking of medical devices inserted into blood vessels requires rapid movement of the mobile C-arm device in a back and forth series. For example, the chasing or tracking of a catheter tip as it enters a knee area and then is brought back and forth up into the thigh area of a patient, requires precise, quick movements which are extremely difficult to perform by manual maneuvering of the C-arm device. This task is very cumbersome, difficult, and often impossible to accomplish.
In summary, heretofore C-arm imaging or imaging equipment were either permanently fixed and secured to the floor and/or ceiling of a dedicated room, or consisted of mobile C-arm imaging systems that were manually pushed or pulled throughout the hospital. The key words here are "apermanently", "fixed" and "manually." In particular, mobile C-arm imaging systems did not have motorized carts or carriages.
There were some radiographic units, used to take a plain X-ray of a patient's body, that were attached to a minimally motorized base, cart, or carriage. However, such bases, carts, or carriages were motorized only to move in a limited fashion to transport such equipment down a hallway. The motorized bases, carts, or carriages on these radiographic systems were used just to get the unit from the radiology department up to the patient's beds, because of the size and weight of the equipment.
Such radiographic equipment is extremely heavy, bulky, and most workers within a hospital or clinic are generally incapable of pushing such heavily weighted units. For example, some of these minimally mobile radiographic units weigh about three-hundred to eight-hundred pounds (300 to 800 lbs.) each. Consequently, they are provided with large, imprecise, motorized wheels that simply drive the unit into an elevator or down a hallway. Such motorized wheels are not used during the performance of the medical procedures.
As may be appreciated, the manipulation of such heavy, massive, and bulky equipment requires a considerable amount of space and is thus of limited utility where access is limited. The space requirement for operation of this equipment also necessitates use within a considerably larger room. Not only does the manipulation of this equipment require additional space, but the cumbersome size and shape of the equipment itself severely limits the utility of these devices.
Once positioned adjacent to a patient, such equipment must be manhandled into position and the wheels are locked into a stationary, nonmoving position. Due to their excessive weight, these devices are quite difficult to push.
Once such equipment is placed into position, the equipment stays put, fixed, and is not moved until the procedure is completed. In other words, such equipment is not motorized when placed adjacent to a patient.
The following patents and materials describe a wide variety of different imaging machinery: Janssen et al. (U.S. Pat. No. 4,481,656, issued Nov. 6, 1984); Pajerski et al. (U.S. Pat. No. 4,697,661, issued Oct. 6, 1987); Barud (U.S. Pat. No. 4,716,581, issued Dec. 29, 1987); Louiday (U.S. Pat. No. 4,866,751, issued Sep. 12, 1989); Koropp (U.S. Pat. No. 4,868,845, issued Sep. 19, 1989); Hahn et al. (U.S. Pat. No. 4,872,192, issued Oct. 3, 1989); Van Steenburg (U.S. Pat. No. 4,912,754, issued Mar. 27, 1990); Sebring (U.S. Pat. No. 4,960,271, issued Oct. 2, 1990); Kaul et al. (U.S. Pat. No. 5,008,921, issued Apr. 16, 1991); Van Steenburg (U.S. Pat. No. 5,048,071, issued Sep. 10, 1991); Hughes (U.S. Pat. No. 5,147,002, issued Sep. 15, 1992); Sebring (U.S. Pat. No. 5,156,166, issued Oct. 20, 1992); Kraft (U.S. Pat. No. 5,350,033, issued Sep. 27, 1994); Harrawood et al. (U.S. Pat. No. 5,386,453, issued Jan. 31, 1995); Schaefer et al. (U.S. Pat. No. 5,425,068, issued Jun. 13, 1995); Pellegrino et al. (U.S. Pat. No. 5,425,069, issued Jun. 13, 1995); O'Farrell, Jr. et al. (U.S. Pat. No. 5,426,683, issued Jun. 20, 1995); Galando (U.S. Pat. No. 5,475,730, issued Dec. 12, 1995); Pellegrino et al. (U.S. Pat. No. 5,499,284, issued Mar. 12, 1996); Aoki et al. (U.S. Pat. No.5,503,416, issued Apr. 2, 1996); Kadowaki et al. (U.S. Pat. No. 5,544,217, issued Aug. 6, 1996); Hanover (U.S. Pat. No. 5,583,909, issued Dec. 10, 1996); Tanaka (Japan Patent No. 3-251,230(A), issued Nov. 8, 1991); and Philips brochure titled "BV212, Broaden your vision" (date of publication unknown).
The primary problems with the aforementioned systems include the requirements and limitations that: (a) a specially constructed or renovated and extremely expensive room be built to house such equipment; (b) such room must be dedicated solely to use with such equipment; (c) such equipment is inappropriate for use within a sterile environment of an operating room; (d) a patient be transported to the equipment; (e) such heavy and bulky mobile equipment be manually pushed or pulled through a crowded hallway or corridor; (f) such heavy and bulky minimally mobile equipment be manually pushed, manipulated, positioned, repositioned, and then removed from a traditionally very small operating room; (g) use of such heretofore known devices is extremely time consuming because the device must be manually moved and repeatedly repositioned; (h) use of such devices sometimes result in excessive exposure to x-rays along a patient's body and excessive contrast agents being injected into the patient's body; and/or (I) such mobile systems cannot perform multiple tasks simultaneously.
The results of these drawbacks and limitations have far reaching effects in terms of: (a) increasing the cost to construct and maintain special facilities to house such equipment; (b) jeopardizing the safety of patients by prolonging the procedure, exposing the patient to additional x-rays, and increasing the amount of contrast agents; (c) creating a difficult environment within which these medical procedures are conducted due to the manually pushing and pulling of heavy and bulky equipment; (d) requiring the attention of specially skilled individuals to manhandle and operate such equipment; and (e) obtaining less than optimal results from the crude, inaccurate, and inexact methods currently used to position such equipment, all of which significantly increase the cost to perform these medical procedures.
It is firmly believed that the above-listed patents and information, whether taken alone or in combination, neither anticipate nor render obvious the current invention. The foregoing explanation does not constitute an admission that such disclosures or information are relevant or material to the appended Claims. Rather, such disclosures and information relate only to the general field of the current invention and constitute the closest art of which the inventor is aware.